DMPK

QPS' Addition of Senior Pharmaceutical Personnel a Catalyst for New Drug Development

The notion of shepherding a promising drug candidate from IND submission to Phase II proof-of-concept studies is not new. This “soup-to-nuts” approach has been heralded by the CRO industry since the later 1990s as a way for drug companies to shorten drug development timelines. However, unimpressive results during the past two decades raise the question of whether this approach is valid. Can the CRO industry actually accelerate the drug development process beyond simply being more efficient at performing repeated tasks at less expense?

Of late, the pharmaceutical industry has been transformed through consolidation, restructuring, and downsizing. One of the critical consequences of this transformation is the migration of senior industry personnel to either CROs, private consulting or retirement. The attrition of experienced professionals has resulted in an industry “brain drain” but has also created opportunities for CROs to help drug companies accelerate the preclinical and clinical development of drug candidates.

QPS has taken advantage of this opportune environment by aggressively hiring senior drug development professionals from pharma and biotech to build an experienced team that covers DMPK, toxicology, CMC, early clinical, and project management. Members of the “IND Development Team” have filed hundreds of INDs and more than 10 NDAs/MAAs in different therapeutic areas. All IND Development Team members are directly involved with technical operations. They understand the regulatory and scientific requirements for conducting the appropriate number of studies at the right time with the shortest timelines possible to rapidly advance drug candidates from IND submission to Phase II proof-of-concept studies.

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